title: Intra-individual, randomised comparison of the MRI contrast agents gadobutrol versus gadoteridol in patients with primary and secondary brain tumours, evaluated in a blinded read.
abstract: OBJECTIVE
  To prove that 1.0 M gadobutrol provides superior contrast enhancement and MRI image characteristics of primary and secondary brain tumours compared with 0.5 M gadoteridol, thereby providing superior diagnostic information.
  
  
  METHODS
  Brain MRI was performed in two separate examinations in patients scheduled for neurosurgery. Independent injections of 1.0 M gadobutrol and 0.5 M gadoteridol at doses of 0.1 mmol Gd/kg body weight were administered per patient in randomised order. Evaluation was performed in an off-site blinded read.
  
  
  RESULTS
  Fifty-one patients in the full analysis set (FAS) were eligible for efficacy analysis and 44 for the per-protocol analysis. For the primary efficacy variable "preference in contrast enhancement for one contrast agent or the other", the rate of "gadobutrol preferred" was estimated at 0.73 (95 % confidence interval 0.61; 0.83), showing significant superiority of gadobutrol over gadoteridol. Calculated lesion-to-brain contrast and the results of all qualitative secondary efficacy variables were also in favour of gadobutrol. Keeping a sufficient time delay after contrast application proved to be essential to get optimal image quality.
  
  
  CONCLUSIONS
  Compared with 0.5 M gadoteridol, 1.0 M gadobutrol was proven to have significantly superior contrast enhancement characteristics in a routine MRI protocol of primary and secondary brain tumours.
authors.affiliation: Department of Diagnostic and Interventional Radiology and Neuroradiology, Klinikum Luenen St. Marien-Hospital, Lünen, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Koenig
authors.forename: G
authors.initials: G
authors.lastname: Schulte-Altedorneburg
authors.forename: M
authors.initials: M
authors.lastname: Piontek
authors.forename: A
authors.initials: A
authors.lastname: Hentsch
authors.forename: P
authors.initials: P
authors.lastname: Spangenberg
authors.forename: C
authors.initials: C
authors.lastname: Schwenke
authors.forename: A
authors.initials: A
authors.lastname: Harders
authors.forename: L
authors.initials: L
authors.lastname: Heuser
mesh_terms: D000818:Animals; D001921:Brain / Q000473:pathology; D001932:Brain Neoplasms / Q000175:diagnosis* / Q000556:secondary*; D003287:Contrast Media; D005260:Female; D005682:Gadolinium; D006571:Heterocyclic Compounds; D006801:Humans; D007089:Image Enhancement / Q000379:methods*; D008279:Magnetic Resonance Imaging / Q000379:methods; D008297:Male; D008875:Middle Aged; D009942:Organometallic Compounds; D011446:Prospective Studies
chemical_list: D003287:Contrast Media; D006571:Heterocyclic Compounds; D009942:Organometallic Compounds; C062402:gadoteridol; C090600:gadobutrol; D005682:Gadolinium